The manufacturer (VIGMED) has identified that the catheter material (FEP - Fluorinated Ethylene Propylene) in combination with beta-sterilization is more sensitive to repeated kinking than similar vascular catheters of other material and/or sterilization method. Repeated kinking of a beta-sterilized FEP catheter can, in rare cases, result in catheter breakage and may therefore need to be removed by surgical intervention.

Please find a copy of the Field Safety Notice (FSN) and the fax/email back form through this link here.